Device recall
Z-1610-2014: PS-C Femoral Nonporous Rt Sz 6, Model Number 161-1604 Component of the Balanced…
FDA device recall · Class II · Ortho Development Corporation
Key facts
| Recall number (Z-number) | Z-1610-2014 |
|---|---|
| Recall event | 68029 |
| Product | PS-C Femoral Nonporous Rt Sz 6, Model Number 161-1604 Component of the Balanced Knee System and Balanced Knee Revision System, for total knee arthroplasty procedures. |
| Product code | JWH |
| Recalling firm | Ortho Development Corporation |
| Recall class | Class II |
| Status | Terminated |
| Termination date | Jul 14, 2014 |
| 510(k) numbers | K994370 |
| FEI number | 3017298928 |
At a glance
- 1–9 Linked 510(k)s
- 1–9 Products in the same recall event
- 100–999 Recalled products with this product code
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA device recalls (products)
Each recalled device product receives a Z-number. Recall details such as root cause, distribution and firm actions are available in Orca1.
Source: U.S. Food and Drug Administration (FDA), Medical Device Recalls database